Predictive Value of SFlt-1/PlGF Ratio for the Diagnosis of Cardiovascular Disorders in the Puerperium: Pilot Study (SOMP)
Study Overview
Status
Conditions
Detailed Description
At the time of recruitment, patients will be adequately informed about the purpose and modality of the study and will sign an informed consent form for participation in the study. On the first postpartum day, on the occasion of the blood tests included in the normal care routine, the patients will undergo measurement of circulating levels of angiogenic factors (soluble fms-like tyrosine kinase, sFlt-1; placental growth factor, PlGF), already used in pregnancy for predicting the risk of early and late preeclampsia. Marker assay kits will be provided free of charge by the company DASIT. Prior to collection, systolic and diastolic blood pressure will be measured by manual sphygmomanometer in supine position after at least 15 minutes of rest.
Anamnestic, clinical and laboratory data regarding pregnancy, childbirth and puerperium will be collected.
A diary for recording blood pressure values in the puerperium will be provided on the same occasion. The patient will be instructed in home blood pressure monitoring which should take place twice a week for the next 6 weeks after delivery. Return of the diary containing the pressure data will be done by e-mail. Postpartum hypertension is defined according to ACOG criteria as a systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. If altered blood pressure values are found, the patient will be invited to go to the emergency department or to her primary care physician and treated according the usual clinical practice.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bologna, Italy, 40138
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 18 years and < 44 years
- Single pregnancy
- Understanding and obtaining informed consent
Exclusion Criteria:
- Language misunderstanding
- Twin pregnancies
- Inability to comply with study arrangements (e.g., inability to home recording of blood pressure values)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Hypertensive disorders in the puerperium
Identification of a risk stratification model and its predictive value for cardiovascular disorders in the puerperium
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Identification of a risk stratification model for cardiovascular/hypertensive disorders in the puerperium using a panel of placental biochemical markers (sFlt-1 and PlGF: already used in pregnancy for prediction of preeclampsia), demographic, clinical and laboratory data.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of a risk stratification model and its predictive value for cardiovascular/hypertensive disorders in the puerperium (6 weeks after delivery)
Time Frame: "From enrollment to the end of treatment (6 weeks after delivery)
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Through a panel of placental biochemical markers (sFlt-1 and PlGF: already used in pregnancy to predict preeclampsia), demographic, clinical and laboratory data.
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"From enrollment to the end of treatment (6 weeks after delivery)
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Collaborators and Investigators
Investigators
- Principal Investigator: Antonio Farina, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOMP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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